BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINCO RECLINER

    MDR report key: 7568927 · Received June 4, 2018

    Report

    Report Number
    MW5077640
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 18, 2018
    Manufacturer
    WINCO MFG LLC
    Product Code
    FRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SITTING IN THE RECLINER AND ATTEMPTED TO STAND BY PUSHING HIMSELF UP ON THE ARMS OF THE RECLINER. THE SIDE ARM UNEXPECTEDLY SWUNG OPEN AND HE FELL, FRACTURING HIS HIP. HE REQUIRED TRANSFER TO A TERTIARY CARE FACILITY AND HIP SURGERY. THE SIDE ARM HAD NOT BEEN OPENED OR USED AT ALL DURING THIS PT'S STAY BY STAFF OR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408457 WINCO RECLINER TREATMENT RECLINER WITH SWING-ARM FEATURE FRJ WINCO MFG LLC INVERNESS 24-HOUR

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O| R